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Basic Drug Info
Drug Name:Diltia XT
Manufacturer:Watson Pharma, Inc.
Other Info:

Sublingual Nitroglycerin may be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy.Prophylactic Nitrate Therapy— Diltiazem hydrochloride may be safely co-administered with short- and long-acting nitrates.Beta-blockers.

(See WARNINGS and PRECAUTIONS.)Antihypertensives— Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents.

Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other.



Clinical Trials:


Indications and Usage

Diltiazem hydrochloride extended-release capsules USP (Once-a-day dosage) are indicated for the treatment of hypertension.

Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics.Diltiazem hydrochloride extended-release capsules USP (Once-a-day dosage) are indicated for the management of chronic stable angina.
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Contraindications
Diltiazem hydrochloride is contraindicated in: (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker; (2) patients with second or third degree AV block except in the presence of a functioning ventricular pacemaker; (3) patients with hypotension (less than 90 mmHg systolic); (4) patients who have demonstrated hypersensitivity to the drug; and (5) patients with acute myocardial infarction and pulmonary congestion as documented by X-ray on admission.
Sick Sinus Syndrome -- A condition caused by dysfunctions related to the SINOATRIAL NODE including impulse generation (CARDIAC SINUS ARREST) and impulse conduction (SINOATRIAL EXIT BLOCK). It is characterized by persistent BRADYCARDIA, chronic ATRIAL FIBRILLATION, and failure to resume sinus rhythm following CARDIOVERSION. This syndrome can be congenital or acquired, particularly after surgical correction for heart defects.

Complete atrioventricular block -- Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Acute myocardial infarction --

Warnings

Cardiac Conduction.

Diltiazem hydrochloride prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome.

This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second, or third degree AV block (22 of 10,119 patients, or 0.2%); 41% of these 22 patients were receiving concomitant ?-adrenoceptor antagonists versus 17% of the total group.

Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction.

A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single 60 mg dose of diltiazem.

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